Using computer simulations to improve treatment for atrial fibrillation
Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation
This study is testing if using computer simulations can help doctors create personalized treatment plans for people with atrial fibrillation who are getting heart procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 115 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 2 sites (Edinburgh and 1 other locations) |
| Trial ID | NCT05057507 on ClinicalTrials.gov |
What this trial studies
This research aims to classify patients with atrial fibrillation based on the dominant mechanism of their heart's electrical activation. By utilizing a combination of computer modeling and patient data, the study seeks to identify the unique electrical circuits responsible for atrial fibrillation in each patient. Participants scheduled for an ablation procedure will undergo various assessments, including cardiac imaging and ambulatory monitoring, to gather comprehensive data. The goal is to develop tailored treatment strategies that could enhance the effectiveness of ablation procedures.
Who should consider this trial
Good fit: Ideal candidates are individuals with symptomatic paroxysmal or persistent atrial fibrillation who are scheduled for radiofrequency ablation.
Not a fit: Patients with contraindications to ablation or those with conditions limiting life expectancy to less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatments for patients with atrial fibrillation.
How similar studies have performed: While the approach of using computer simulations in electrophysiology is innovative, similar studies have shown promise in improving treatment outcomes for arrhythmias.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation diagnosed - within 24 months preceding the consent date. * Planned radiofrequency ablation for atrial fibrillation consisting of pulmonary vein isolation. * Able and willing to comply with study follow-up requirements * Able and willing to provide written informed consent Exclusion Criteria: * Any clinical contra-indication to ablation * Any disease limiting life expectancy to \< 1year * Contra-indication to MRI including renal dysfunction (eGFR\<30ml/min) * Potential participant currently pregnant or breast feeding * Prior ablation, cardiac surgery or presence of any prosthetic valves * Myocardial infarction or percutaneous coronary intervention within 3 months preceding consent date * Hypertrophic cardiomyopathy or other inherited cardiac condition * Presence / likely implant of any pacemaker, cardiac resynchronization therapy device or implantable defibrillator within 1 year * Enrolment in an existing interventional atrial fibrillation study which alters treatment or follow-up. * Use of amiodarone for any indication within 6 months prior to the planned ablation procedure * Use of any anti-arrhythmic drug for an arrhythmia indication other than atrial fibrillation * Prior documented cavotricuspid isthmus dependent right atrial flutter and planned cavotricuspid isthmus ablation to be performed at the time of atrial fibrillation ablation * Unable to understand verbal or written explanations given in English or German as appropriate.
Where this trial is running
Edinburgh and 1 other locations
- NHS Lothian — Edinburgh, United Kingdom (Recruiting)
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Mark D O'Neill, FRCP — Guy's and St Thomas' NHS Foundation Trust
- Study coordinator: Steven E Williams, MRCP
- Email: steven.williams@ed.ac.uk
- Phone: +44-(0)-131 242 6515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.